Sodium Citrate and Citric Acid

Solution · Oral

Prescription (Rx) Anti-coagulant Calculi Dissolution Agent

Uses

Sodium citrate and citric acid oral solution, is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium citrate and citric acid oral solution is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.

Dosage and administration

Sodium citrate and citric acid oral solution should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING. For Systemic Alkalization Usual Adult Dose 2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. Usual Pediatric Dose 1 to 3 teaspoonfuls (5 to 15 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician. As a neutralizing buffer 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician.

Contraindications

Patients on sodium-restricted diets or with severe renal impairment.

Precautions

Sodium citrate and citric acid oral solution should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

Side effects

Sodium citrate and citric acid oral solution is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia.

Overdosage

Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions.

Description

Sodium Citrate and Citric Acid Oral Solution, USP is a clear stable and cherry flavored systemic alkalizer containing sodium citrate and citric acid in a sugar-free base with cherry flavor. It is a nonparticulate neutralizing buffer. Sodium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL): Sodium Citrate Dihydrate, USP 500 mg (0.34 Molar) Citric Acid Monohydrate, USP 334 mg (0.32 Molar) Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO 3 ). INACTIVE INGREDIENTS: purified water, saccharin sodium, sodium benzoate, sorbitol solution, and wild cherry flavor.

How supplied

Sodium Citrate and Citric Acid Oral Solution, USP (Colorless liquid with cherry flavor) is supplied in the following oral dosage form: Unit Dose Cup 15 mL: NDC 68999-868-51 20 Unit Dose Cups of 15 mL each : NDC 68999-868-24 Unit Dose Cup 30 mL: NDC 68999-869-43 20 Unit Dose Cups of 30 mL each : NDC 68999-869-24 STORAGE: Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from freezing. Rx ONLY Manufactured for: Chartwell Governmental & Specialty RX, LLC. Congers, NY 10920 L72916 Rev. 02/2026

Label text from the FDA structured product label by Chartwell Governmental & Specialty RX, LLC (revised Apr 7, 2026). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Sodium Citrate and Citric Acid NDC products (15)

NDCStrength & formLabelerType
60687-832Sodium Citrate, Unspecified Form 1500 mg/15mL; Anhydrous Citric Acid 1002 mg/15mL
Solution
American Health PackagingUNAPPROVED DRUG OTHER
60687-834Sodium Citrate, Unspecified Form 3000 mg/30mL; Anhydrous Citric Acid 2004 mg/30mL
Solution
American Health PackagingUNAPPROVED DRUG OTHER
17856-0595Sodium Citrate 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
Atlantic Biologicals Corp.UNAPPROVED DRUG OTHER
50268-182Sodium Citrate 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
AvPAKUNAPPROVED DRUG OTHER
50268-183Sodium Citrate 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
AvPAKUNAPPROVED DRUG OTHER
84447-017Sodium Citrate 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
Belleview Biosciences LLCUNAPPROVED DRUG OTHER
55154-5777Sodium Citrate, Unspecified Form 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
Cardinal Health 107, LLCUNAPPROVED DRUG OTHER
68999-868Sodium Citrate 1500 mg/15mL; Citric Acid Monohydrate 1002 mg/15mL
Solution
Chartwell Governmental & Specialty RX, LLCUNAPPROVED DRUG OTHER
68999-869Sodium Citrate 3000 mg/30mL; Citric Acid Monohydrate 2004 mg/30mL
Solution
Chartwell Governmental & Specialty RX, LLCUNAPPROVED DRUG OTHER
62135-434Sodium Citrate 500 mg/5mL; Citric Acid Monohydrate 334 mg/5mL
Solution
Chartwell RX, LLCUNAPPROVED DRUG OTHER
62135-868Sodium Citrate 1500 mg/15mL; Citric Acid Monohydrate 1002 mg/15mL
Solution
Chartwell RX, LLCUNAPPROVED DRUG OTHER
62135-869Sodium Citrate 3000 mg/30mL; Citric Acid Monohydrate 2004 mg/30mL
Solution
Chartwell RX, LLCUNAPPROVED DRUG OTHER
81033-017Anhydrous Citric Acid 334 mg/5mL; Sodium Citrate 500 mg/5mL
Solution
Kesin Pharma CorporationUNAPPROVED DRUG OTHER
0121-0595Sodium Citrate 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
Pharmaceutical Associates, Inc.UNAPPROVED DRUG OTHER
0121-1190Sodium Citrate 500 mg/5mL; Anhydrous Citric Acid 334 mg/5mL
Solution
Pharmaceutical Associates, Inc.UNAPPROVED DRUG OTHER

Frequently asked questions

What is Sodium Citrate and Citric Acid used for?

Sodium citrate and citric acid oral solution, is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is…

What are the side effects of Sodium Citrate and Citric Acid?

Sodium citrate and citric acid oral solution is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia. See the full label for the complete list.

Who makes Sodium Citrate and Citric Acid?

Sodium Citrate and Citric Acid is listed by 9 labelers in the FDA NDC directory, including American Health Packaging, Atlantic Biologicals Corp., AvPAK, Belleview Biosciences LLC.